Gildeuretinol Acetate versus Placebo for Geographic Atrophy Secondary to Age-Related Macular Degeneration: The Study of ALK-001 in Geographic Atrophy Randomized Clinical Trial.
Ophthalmol RetinaJun 3, 2026 (epub)
David S Boyer, Leonide Saad, Ilyas Washington et al.
✦ AI-curated · Sources linked
In 30 seconds
This randomized, placebo-controlled trial evaluated gildeuretinol acetate in 198 participants aged ≥60 years with geographic atrophy (GA) over 24 months. Although the primary endpoint of GA growth rate was not met (1.62 mm²/yr vs 1.87 mm²/yr, P = 0.075), secondary analyses indicated a 15.3% relative reduction in GA growth from 6 to 24 months (P = 0.047) and improved visual function outcomes with gildeuretinol.
Key findings
- Mean GA growth rates were 1.62 mm²/yr with gildeuretinol versus 1.87 mm²/yr with placebo (P = 0.075).
- LLVA declined by 3.9 letters with gildeuretinol compared to 8.3 letters with placebo (difference: 4.4 letters, P = 0.031).
- Visual Function Questionnaire-25 scores declined 4.81 fewer points with gildeuretinol than placebo (P = 0.017).
- FRI scores declined 0.35 fewer points with gildeuretinol compared to placebo (P = 0.004).
Why it matters
The findings suggest that gildeuretinol acetate may offer some benefits in slowing GA progression and improving visual function, warranting further investigation in larger trials to confirm these effects.